BEUDAMED
    FDA Recall Terminated

    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place

    Recall: Z-1319-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-1319-2016
    Event Number
    73334
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    IDT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 16, 2016
    Terminated
    August 23, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    Description

    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place

    Reason

    Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.

    Action

    ThermoFisher sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 15, 2016, to all affected customers. The letter contained the following instructions: If you have the above lot in your possession, please determine whether the bags are labeled as Type 3 (PN 8335) or Type 6 (PN 8336). If the product is labeled as Type 3 (PN 8335) please complete the attached Response form with the quantity in inventory and return the form to Richard-Allan Scientific. The product may be used and no further action is required. If the product is labeled as Type 6 (PN 8336) please complete the attached Response form with the quantity in inventory. The product may be used as is or returned to Richard-Allan Scientific. Please indicate on the Response form if the product will be used or a return is desired. Return the completed form to Richard-Allan Scientific. If affected product has been used previously, please complete the attached Response form with the quantity that was used. No further action is required. By returning the attached Acknowledgment Form will facilitate reporting of this matter to the FDA. Customers with questions were instructed to call 269-544-5628.

    Distribution

    Worldwide distribution to AZ , CA , FL , GA , IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom. 6 distributed to OUS accounts: Germany, and the United Kingdom

    Quantity

    29 cases (10 bags per case)